Novel oral therapy for type 2 diabetes wins FDA approval

A new, once-daily oral treatment for patients with type 2 diabetes has been approved by health regulators in America.
Invokana (canagliflozin) is part of a new class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which lower blood glucose levels by blocking the reabsorption of glucose by the kidneys .
The medication, produced by Janssen Pharmaceuticals, has received the green light from the US Food and Drug Administration (FDA) to be used with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
However, it is not suitable for diabetic patients with severe renal impairment, end stage renal disease, or in patients on dialysis, as well as those who have increased ketones in their blood or urine (diabetic ketoacidosis).
The FDA approval makes Invokana the first product in its class to reach the US market, and was based on the results of nine safety and efficacy trials involving 10,285 patients with type 2 diabetes, which showed improvements in HbA1c and fasting plasma glucose levels .
Jimmy Re, head of metabolic medical affairs at Janssen Pharmaceuticals, said: “Invokana provides patients with type 2 diabetes the option of a once-daily oral therapy that offers improved glycemic control and is associated with reductions in body weight and systolic blood pressure.”
As part of the its approval, Janssen will have to carry out five post-marketing studies for Invokana, including a cardiovascular outcomes trial, an enhanced pharmacovigilance programmen, a bone safety study and two paediatric trials.